FOI 127-1314 document 24 part 2

Public Summary ~1Jwtn~!~¥1~i~1~n!i:ifr , ,, 15590 SUISSE LIQUID CHLOROPHYLL 20mg/g Solution bottle

ARTG entry for Medicine

Swisse Wellness Ply ltd Sponsor

Postal Address 36-38 Gipps Street, COLLINGWOOD, VIC, 3066 Australia

ARTG Start Date

Product category

S~atus

Approval area

10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 19

1. LIQUID CHLOROPHYLL 20mg/g solution·

Product Type Single Medicine Product Effective date

No Warnings included on Record

This product accepted for registration/listing as 'currently supplied' at the time of commencement code) .

No Specific Indications included on Record

TGAeBS

Type Material

Not recorded

Conditions

Not recorded

of1

Not scheduled. Not considered by committee

Oral Liquid, solution

Oral

Dark green aqueous liquid

20 mg/g

rk is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

onwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Produced at 20.03.2014 at 02:04:29 EST This.is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

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Public Summary

· ~.!l\ll!!i~~:t~r,~!it.~ ~rf&r• ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

15598 SUISSE ZESTABS Tablet bottle

Medicine

Swisse Wellness Ply Ltd

36-38 Gipps Street, COLLINGWOOD, VIC, 3066 Australia

10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act

TGAeBS

The label of this product's container and primary pack (if any) is to carry the following statement' Warning - thi$,;WCW~J.c recommended for asthma and allergy sufferers as it can cause severe allergic reactions'.


This product accepted for registration/listing as 'currently supplied' at the time code)

Poison Schedule

Closure

Not recorded

Conditions

Not recorded

100 tablets Not scheduled. Not considered by committee

Tablet, uncoated

Oral

Tablet, round, convex faces, diameter 11.17 mm, brown speckled

25mg

10mg

150 mg

16.7mg

37.5 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-copyright.htm.

Page 1of1 Produced at 20.03.2014 at 02:05:07 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Public Summary

L~'ilw!lf~Ntzt~t;e~~t~£w,;: ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

15597 SWISSE WOMEN'S MULTI-VITAMIN & MINERAL FORMULA Tablet bottle

Medicine



10/09/1991

Medicine

Revoked


The label of this product's container and primary pack (if any) is to carry the following statement' Warning - thi recommended for asthma and allergy sufferers as it can cause severe allergic reactions'.

Product Type Single Medicine Product


TGAeBS

This product accepted for registration/listing as 'currently supplied' at the time ns held in ARTG paper records. (Old code)

Biotin

Calcium ascorbate

Calcium citrate

Calcium pantothenate

Carica papaya

Centella asiatica

Chlorophyllin-copper complex

Cholecalciferol

Choline bitartrate

Page 1 of2 This is not an ARTG Certificate document.

Closure

Not recorded

Poison Schedule

Conditions

Not recorded


Tablet, film coated

Oral

Tablet, film-coated, oval with convex faces, approx. 24mm long x 11 mm wide, approx. 1500mg, opaque apricot colour.

25mg

15mg

10mg

25mg

50 microgram

200 mg

200 mg

75mg

5mg

2.5 mg

5mg

201.4 IU

25mg

Produced at 20.03.2014 at 02:05:49 EST

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Chromium amino acid chelate

Copper amino acid chelate

Cyanocobalamin

d-alpha-Tocopheryl acid succinate

Equisetum arvense

Evening Primrose Oil

Ferrous fumarate

Foeniculum vulgare

Folic acid

Ginger

Ginkgo biloba

Inositol

Magnesium oxide

Manganese amino acid chelate

Matricaria recutita

Mentha X cardiaca

Nicotinamide

Oryzanol

Panax ginseng

Petroselinum crispum

Potassium amino acid chelate

Potassium iodide

Pyridoxine hydrochloride

Raspberry

Riboflavine

Royal jelly

Silica - colloidal anhydrous

Thiamine hydrochloride

Ubidecarenone

Zinc amino acid chelate

©Commonwealth of Australia.This work·


TGAeBS

10 microgram

417 microgram

75 microgram

83mg

6mg

10mg

15.2mg

15mg

180 microgram

15mg

7mg

50mg

50mg

1 mg

25mg

ransmit, distribute or commercialise the material without obtaining prior

/www.tga.gov.au/abouVwebsite-copyright.htm.



)

Public Summary

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

15595 SUISSE ULTI C Tablet bottle

Medicine



10/09/1991

Medicine

Revoked

TGAeBS

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions .:!J • Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1



This product accepted for registration/listing as 'currently supplied' at the time of commencement o 00~ .


Type Material

Tablet, film coated

Oral

Not recorded

Conditions

Not recorded

Tablet, capsule shape 22.8 mm long x 9.4 mm wide, convex faces, film coated, cream colour, mottled.

100 mg

1000 mg

41.3 mg

25mg

25mg


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/abouUwebsite-copyright.htm.


)

)

Public Summary !~'lili~~(t~f ·~~J~!~iiJ~~fr(" 15593 SUISSE ULTI B COMPLEX Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

TGAeBS

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions. Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act



This product accepted for registration/listing as 'currently supplied' at the time of commencement o code)


30 tablets

Inositol

Methionine

Nicotinamide


Riboflavine



Tablet

Oral

Not recorded

Conditions

Not recorded

Tablet, round diameter 10.9 mm, convex faces, coated brown (chocolate)

50mg

100 mg

50 microgram

50mg

50mg

50 microgram

400 microgram

100mg

50mg

50mg

50mg

50mg

50mg



)

)

TGAeBS



Page 2 of 2 Produced at 20.03.2014 at 02:08:27 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

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Public Summary -~Mmnx~.:J3t~~~?r~:j;[@i·~ "·' ·.' 15592 SWISSE ODOURLESS GARLIC & HORSERADISH Capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Accepted for R,egistration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act

1. SWISSE HORSERADISH & ODOURLESS GARLIC Capsule



This product accepted for registration/listing as 'currently supplied' at the time of commencement o code) ·


Type Material

Capsule, hard

Oral

Not recorded

TGAeBS

Conditions

Not recorded

Hard capsule size 0 clear containing an off white powder

Calcium ascorbate

Histidine

Thymus vulgaris

Trigonella foenum-graecum

Trigonella foenum-graecum

250 mg

83;4mg

20mg

5mg

50mg

250 mg

1.5mg

241 mg

50mg

20mg

5mg

20mg


written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.


Public Summary ;§.~.mw~~~~~b~!~,~~i~{, T;E,: 15596 SUISSE UL TIMINERAL Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine

Swisse Wellness Pty Ltd


10/09/1991

Medicine

·Revoked

TGAeBS


1. SUISSE Ultimineral tablet bottle




Type Material


Potassium amino acid chelate


Tablet, uncoated

Oral

Not recorded

Conditions

Not recorded

Tablet, capsule shaped, faces convex, grey, speckled, dimensions 17.3mm long x 6 .. 9mm wide

350 mg

50 microgram

2mg

1.65mg

10mg

175 mg

5mg

30mg

10mg




)

Public Summary ',~~p\,~~~'t<iffi~t~;,g~t@f;'( •.. ... 15585 SWISSE HALIBUT LIVER OIL 145mg A PLUS D Capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked



This product accepted for registration/listing as 'currently supplied' at the time of commencement o code}


Type Material

Capsule, soft

Oral

Not recorded

-"'-.

TGAeBS

Conditions

Not recorded

Capsule SEG (soft elastic gelatin}, round seamed 4minim, colour clear white

Page 1of1

145 mg

his work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

onwealth.Further details can be found at http://www.tga.gov.au/abouVwebsite-copyright.htm.

Produced at 20.03.2014 at 02:10:22 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

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Public Summary ~.u.mti!iiw:ror~t§:~ntwf~,. > 15589 SUISSE LIVER EXTRACT 400mg Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions .l/JJ Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 19



This product accepted for registration/listing as 'currently supplied' at the time of commencement code) ·''


TGAeBS

Type Material

Not recorded

Conditions

Not recorded

Page 1of1


Tablet, uncoated

Oral

Tablet, oval, dimensions 23.4 mm long x 10.6 mm wide. Brown (light) with brown (dark) speckle.

400 mg

his work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

onwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.


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Public Summary li1}nitri1¥i!~r;.l\f§'r~;~rj!r¥• \ · 15586 SUISSE HERBAL DIURETIC Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked






Type Material

Not recorded

TGAeBS

Conditions

Not recorded


Tablet, uncoated

Oral

Tablet, round, convex faces, diameter 12mm, green speckled.

50mg

77.Smg

50mg

300 mg

25mg



Page 1of1 Produced at 20.03.2014 at 02:11 :17 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

Public Summary

~Mfufu,~®~f~~-t~?:i~Ji~~Di2',;;'. :& 15581 SUISSE CO ENZYME Q 10 Capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked



This product accepted for registration/listing as 'currently supplied' at the time of commencement o 00~ .

Not recorded

TGAeBS

Conditions

Not recorded


Capsule, hard

Oral

Two piece capsule (hard) clear size o filled with a cream powder

200 mg

10 IU

100 mg

50mg

12mg



Page 1of1 Produced at 20".03.2014 at 02:12:57 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Public Summary

~,~mD1~f¥Jtfit~·Mr~~iJ!wJ;};i• :~ 15583 SUISSE GINKGO BILOBA 200mg Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Accepted for Registration or Listing as Goods Currently Supplied at tjle Commencement of the Therapeutic Goods Act 1

1. Ginkgo Biloba Tablet





Not recorded

Tablet, uncoated

Oral

TGAeBS

Conditions.

Not recorded

Tablet, round, diameter 11.26 mm, convex faces, grey with brown mottles

Page 1of1

200 mg

rk is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

. onwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.


)

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Public Summary §Y~ill~f¥i!§[;,~1~?Mt')t~~ .. __ " 15587 SUISSE INOSINE Tablet bottle

ARTG entry for

Spon~or

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Accepted for Registration or Listing as (3oods Currently Supplied at the Commencement of the Therapeutic Goods Act

1. INOSINE tablet



This product accepted for registration/listing as 'currently supplied' at the time of commencement o code) ··


Type Material

Not recorded

Tablet, uncoated

Oral

TGAeBS

Conditions

Not recorded

Tablet, capsule shape convex faces, 22.6 mm x 9.3 9.3mm, white

Page 1of1

500 mg

30mg

10mg

.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.


)

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Public Summary ~~mrfii.Y·!otM~§-~n~f:¥;. '', , · · 15588 SUISSE LIPOTROPIC FAT EMULSIFIERS Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions"' Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act l9



This product accepted for registration/listing as 'currently supplied' at the time of commencement o code) · ·


TGAeBS

Type

Not recorded

Conditions

Not recorded

Liver extract

Medicago saliva

Methionine

Pancreatin


Stellaria media

Not scheduled. Not considered by committee,


Tablet, film coated

Oral

Tablet, capsule shape, dimensions 22.7 mm long x 9.3 mm wide. Convex faces, film coated. Light brown speckled.

100 mg

500 mg

10mg

250 mg

20mg

5mg

10 mg

100mg

20mg

25mg

5mg


Page 1 of2 Produced at 20.03.2014 at 02:14:22 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

TGAeBS


Page 2 of 2 Produced at 20.03.2014 at 02:14:22 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Public Summary ;§"ufilm!ii&A1i~:M1~:~'1Jcy;; i),; 1ss82 SUISSE GARLIC & HORSERADISH COMPLEX Tablet bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine



10/09/1991

Medicine

Revoked




This product accepted for registration/listing as 'currently supplied' at the time of commencement code) ~


Type Material

Tablet, uncoated

Oral

Not recorded

TGAeBS

Conditions

Not recorded

Tablet, round, convex faces, diameter 12.08 mm, grey speckled

167mg

12.5mg

100 mg

50mg

50mg




)

Public Summary

;§~ro,~~!fi~t?l~Mt~;~S!,t~; ' .. ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

15584 SUISSE HAIR & NAIL Tablet bottle

Medicine



10/09/1991

Medicine

Revoked





No Specific Indications' included on Record

Type Material

Not recorded

TGAeBS

Conditions

Not recorded


Tablet

Oral

Tablet, round, convex faces, diameter 11.3 mm, light green speckled

424 mg

230 mg

8.3mg

25mg




)

TGAeBS

Public Summary

>~?cit1rV~.!Ycf<i~·M~~~~t!)I; .. <. ,1::~> ':::-'' _,,

129846 SWISSE MEN'S ULTIVITE MULTIVITAMIN, MINERAL AND ANTI-OXIDANT FORMULA 1 WITH HERBS (CAPSULE}

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



31/07/2006

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b} Identify the manufacturer(s} of each batch of the listed medicine. Where any part of or step in manufacture in sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agr kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period offive years and to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertisi;i the medicine for in relation to the inclusion of the medicine in the Register., ·

be

All reports of adverse reactions or similar experiences associated with the use or administrati of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of listed medicines must retain records of such reports for a period of not less than 18 months from

tified to the Head, Office f those reports. Sponsors

e of Product Review is notified of the report or reports.,

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quali Manager Therapeutic Goods Administration, immediately the

Colouring agents used in listed medicine for ingestion, be only those included in the list of 'Colourings per http://www.tga.gov.au/industry/cm-colourings-o

action taken in relation to the medicine in Australia, must be notified to the National

section 25 of the Therapeutic Goods Act 1989, shall

NTl-OXIDANT FORMULA 1 WITH HERBS

28/08/2009 9:44:39 AM

e is inadequate. OR Vitamin supplements should not replace a balanced diet.,

r per ml or per gram of product] [must be clear and legible].,

doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

assist in maintaining normal blood. Blood tonic.,

Male support. Balances and supports normal male physiology and function.,

Aids, assists or helps in the maintenance or improvement of general well-being.,

Beneficial during times of stress. [Warning S required],

Helps relieve nervous tension, stress and mild anxiety. [Warning S required],

For mineral (may state the mineral} supplementation.,

For vitamin (may state the vitamin} supplementation.,

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron deficiency conditions}.,

May assist in the management of dietary folate deficiency .

. :·~~~~~U!~}r~,~~~t~I'J~1~~~§~~-[~i :;~~,, ,; ;5~-t-i:~ ;/,~f51~r~",f? '.r~: t~:·:ri:;it~!:~~r~;Ji:I&};;~i Page 1 of3 Produced at 13.03.2014 at 12:09:27 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

TGAeBS

Designed to meet men's nutritional needs and general well-being. The herbal ingredients in this formulation may help men perform in peak condition and improve stress adaptation.

Dosage Form

Route of Administration

Visual Identification

A~tivel~gr~clien~~ ·•

Apium graveolens

Equivalent: Apium graveolens (Dry)

Astragalus membranaceus

Equivalent: Astragalus membranaceus (Dry)

Avena sativa

Equivalent: Avena saliva (Fresh)

Barosma betulina

Equivalent: Barosma betulina (Dry)

Barberis vulgaris

Equivalent: Barberis vulgaris (Dry)

Biotin

Calcium ascorbate dihydrate

Calcium citrate


Camellia sinensis

Equivalent: Camellia sinensis (Dry)

Carica papaya

Centella asiatica

Equivalent: Cantella asiatica (Dry)

Cholecalciferol

Choline bitartrate

Chromium picolinate

Copper gluconate

Equivalent: Foeniculum vulgare (Dry)

Folicacid

Ginkgo biloba

Equivalent: Ginkgo biloba (Dry)

Inositol

Lutein

Lycopersicon esculentum

Lysine hydrochloride

Magnesium oxide - heavy


Poison Schedule

Capsule, hard

Oral

1.67 mg

10mg

5mg

6.25mg

25mg

.0025mg

12.5mg

25 microgram

20mg

100 microgram

12.5 mg

50mg

15 microgram

6.25 mg

25mg

20.256 mg

3.75 mg

15mg

4.8 mg

1.7 mg

7.5mg

250 microgram

1 mg

50mg

12.5 mg

100 microgram

25mg

50mg




Nicotinamide

Panax ginseng

Equivalent: Panax ginseng (Dry)


Potassium iodide

Potassium sulfate


Riboflavine

Selenomethionine

Serenoa repens

Equivalent: Serenoa repens (Dry)

Silybum marianum

Smilax officinalis

Equivalent: Smilax officinalis (Dry}

Spearmint Oil


Turnera diffusa

Equivalent: Turnera diffusa (Dry)

Tyrosine

Ubidecarenone

Vaccinium myrtillus

Vitis vinifera


Zingiber officinale

Equivalent: Zingiber officinale (Dry)

©Commonwealth of Australia.This work is copyright.Yo

written approval from the Commonwealth.Further de!


6mg

15 mg

8.33mg

25mg

5mg

33 microgram

4.46mg

15mg

15 mg

TGAeBS

32.5 microgram

10 mg

te or commercialise the material without obtaining prior

/about/website-copyright.him.



)

Public Summary $.U,i;rim~i)'t9rA~J;G;~ritrY,:.

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

124329 Swisse Ultiboost Bone Dense

Medicine Listed



19/12/2005

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austra

TGAeBS

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen ion t · be kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and sh to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine i in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such. reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the,·

Where a listed medicine is distributed overseas as well as in Aust outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

Colouring agents used in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! http://www.tga.gov.au/industry/cm-colourings-oral-u

ction 25 of the Therapeutic Goods Act 1989, shall

Material

31/05/201112:08:48 PM

night because the mineral flux in your body that maintains bone growth is greatest during sleep. unts of calcium without the necessary supplementary nutrients may hinder the rate of calcium absorption.

uld be combined with weight bearing exercises, as determined by your Health Care Practitioner, to assist In increasing osteoporosis in later life. ct bones and teeth

Closure Type

Jar/Can Not recorded

Life Time

Not recorded

Temperature

Not recorded Not recorded

Conditions

Not recorded

Dosage Form



Poison Schedule

Tablet, film coated

Oral



)

) . ./


Active lngre!lie.nts


Calcium carbonate

Cholecalciferol

Chromic chloride

Copper gluconate

Magnesium aspartate

Magnesium oxide • heavy

Magnesium phosphate


Potassium aspartate

Potassium iodide

Zinc sulfate monohydrate

Page2 of2 This is not an ARTG Certificate document.

50mg

750mg

.012 mg

TGAeBS

51 microgram

250 microgram

SO mg

461.95 mg

150 mg



~ ~ c:r ~ 1--l • 0 r./) ~ s s ~

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TGAeBS

Public Summary §~.~~~~~tst:~~t%~,n!f¥~ ~;-~,. 122610 Swisse Men's Ultivite Multi-Vitamin Mineral & Anti-oxidant Formula 1 with herbs (tablets)

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



12/10/2005

Medicine

Revoked

Listed Medicines

~ .. -

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept ..

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and s to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine in relation to the inclusion of the medicine in the Register ..

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the-


be

Colouring agents used in listed medicine for ingestion, othe ction 25 of the Therapeutic Goods Act 1989, shall be only those included in the list of 'Colourings permi · http://www.tga.gov.auflndustry/cm-colourings-oral

Where the medicine is a conventional release f the additional conditions are as follows: Where this medicine must comply with the diss Tablets. Where the medicine contai dissolution requirements in the U Supplement. The dissolution c shelf life of the product when the analytical methods fort

rm, of strength of 100 micrograms or more per dosage unit, gle active ingredient, the dissolution characteristics for folic acid in acopoeia 24th Edition (USP24) monograph for Felic Acid

aracteristics for folic acid in this medicine must comply with the P24) monograph for Nutritional Supplements, as amended by its First

ith the dissolution requirements of the relevant USP24 monograph over the duct label. It is the responsibility of manufacturers to develop and validate in conjunction with the USP24 dissolution criteria. This condition does not

apply to chewable, effe ined release tablets.

Effective date 28/08/2009 9:44:39 AM

uin which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

uantity per dosage unit or per ml or per gram of product] [must be clear and legible].,

If symptoms persist consult your healthcare practitioner (or words to that effect).,

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.


May assist in the management of dietary folate deficiency ..

Source of folic acid. Can assist in maintaining normal blood.,

Source of folic acid. Can assist in maintaining normal blood. Blood tonic.,

Male support. Balances and supports normal male physiology and function.,

Helps relieve nervous tension, stress and mild anxiety. [Warning S required],




)

)

TGAeBS

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron deficiency conditions).,

For vitamin (may state the vitamin) supplementation.,

For mineral (may state the mineral) supplementation.,

Beneficial during times of stress. [Warning S required]

Designed to meet men's nutritional needs and general well-being. The herbal ingredients in this formulation may help men perform in peak condition and improve stress adaptation.

Dosage Form



.Active.J~gretti,Elht~•

Apium graveolens




Avenasativa


Barosma betulina


Berberis vulgaris


Biotin


Calcium citrate


Camellia sinensis

Equivalent: Camellia sine ·

Carica papaya


Dunaliella salina

Equisetum arvense

Equivalent: Equisetum arvense (Dry)

Ferrous fumarate

Foeniculum vulgare


Folic acid

Ginkgo biloba


;(

Poison Schedule

Tablet, film coated

Oral

10mg

2.5mg

15mg

50 microgram

200 mg

100 mg

70mg

3.34mg

20mg

10mg

12.5 mg

50mg

.005mg

25mg

50 microgram

40mg

200 microgram

25mg

100 mg

30 microgram

12.5mg

50mg

41.33 mg

7.5 mg

30mg

9.61 mg

3.41 mg

15 mg

500 microgram

2mg



)

)


Inositol

Lutein


Lysine hydrochloride



Nicotinamide

Panax ginseng



Potassium iodide

Potassium sulfate


Riboflavin e

Selenomethionine

Serenoa repens


Silybum marianum

Smilax officinalis

Equivalent: Smilax officinalis (Dry)

Spearmint Oil


Tocopherols concentrate - mixed (low-alpha type)

Turnera diffusa


Tyrosine

Ubidecarenone

Vaccinium myrtillus

Vitis vinifera


Zingiber officinale



100 mg

25mg

.2mg

SO mg

100 mg

12mg

30mg

16.67 mg

50mg

5mg

TGAeBS

ot permitted to re-transmit, distribute or commercialise the material without obtaining prior

ound at http://www.tga.gov.au/about/website-copyright.htm.



)

)

TGAeBS

Public Summary

·~IJ~rn.~rr:~c?r1~1~•i::~~l'g,·•· ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

123100 H 810-JUVEN HAIR NAILS SKIN MINERAL & HERBAL FORMULA WITH ADDED VITAMINS

Medicine Listed



26/10/2005

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austr sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept.,



All reports of adverse reactions or similar experiences associated with the use or admini of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the

Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a ·

be

Colouring agents used in listed medicine for ingestion, othe be only those included in the list of 'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-u

lion 25 of the Therapeutic Goods Act 1989, shall

Pack Size

Dosage Form



Activl! Ingredients

Biotin


28/08/2009 9:44:39 AM

is inadequate. OR Vitamin supplements should not replace a balanced diet.

Poison Schedule

Capsule, hard

.oral

200 microgram



)


Calcium citrate


Cholecalciferol

Citrus bioflavonoids extract

Cyanocobalamin

Cysteine hydrochloride

Cystine


Dunaliella salina

Equisetum arvense


Ferrous fumarate

Folic acid

Ginkgo biloba


Nicotinamide

Panicum miliaceum

Potassium iodide


Riboflavine

Salvia officinalis



Zingiber officinale

written approval from the Commonwealth.Further det


60mg

50mg

25mg

.25 microgram

40 mg

25 microgram

60mg

20mg

10.0032 mg

12.5mg

50mg

TGAeBS

commercialise the material without obtaining prior

about/website-copyright.htm.



)

)

Public Summary §"!,1)fifrl~~ t,9r ~~f §;c~,~i:r,r:'J > 100430 Childvite2

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



29/03/2004

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austra

TGAeBS

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen ion t be kept.,

The sponsor shall retain records of the distribution of the listed.medicine for a period of five years and sha to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine~ in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro· of the report or reports.,



4/1012007 11 :00:00 PM

ula selected herbs to promote stamina, endurance and well-being.

Dosage Form



Active 1rigr11diehts

Ascorbic acid

Biotin

Calcium carbonate




ant Formula in powder form has been formulated specifically for children cif all ages, including those ite 2 has been specially formulated with selected vitamins, minerals, antioxidants and herbs to na and endurance. The vitamin, mineral and antioxidant ingredients have been added to assist in promote stamina and endurance.

Poison Schedule

Oral Liquid, powder for

Oral

5mg/g

3 microgram/g

5.25 mg/g

200 microgram/g

200 microgram/g



)

)

Cyanocobalamin

Eleutherococcus senticosus

Equivalent: Eleutherococcus senticosus (Dry)

Ferrous sulfate - dried

Folic acid

Magnesium aspartate

Manganese sulfate monohydrate

Nicotinamide


Riboflavin sodium phosphate


Urtica dioica

Equivalent: Urtica dioica (Dry)


TGAeBS

300 ng/g

39 microgram/g

643.5 microgram/g

700 microgram/g

1.5 microgram/g

2.4mg/g

50 microgram/g

1 mg/g

200 microgram/g

130 microgram/g

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commerc

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-cop

Page 2 of2 Produced at 13.03.2014 at 11 :59:04 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

TGAeBS

Public Summary 122391 SWISSE WOMEN'S ULTIVITE MUL Tl-VITAMIN MINERAL & ANTI-OXIDANT FORMULA 1 WITH HERBS

(CAPSULE)

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



4/10/2005

Medicine

Revoked

Listed Medicines

1. SWISSE WOMEN'S UL TIVITE MUL Tl-VITAMIN MINERAL & ANTI-OXIDANT FORMULA (CAPSULE)


Contains caffeine [state quantity per dosage unit or per ml or per gram of product] [must be clear and legible]..

Do not take while on warfarin therapy without medical advice.,

If symptoms persist consult your healthcare practitioner (or words to that effect).,

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms~ be exceeded.,

Vitamins can only be of assistance if the dietary vitamin intake is inadequate.

Contains lactose (or words to that effect).

Source of folic acid. Can assist in maintaining normal blood.,

Source of folic acid. Can assist in maintaining normal blood ..

Beneficial during times of stress. [Warning S requir

For mineral (may state the mineral) supplementa ·

Prevention/treatment of vitamin [XX] an deficiency conditions).,

s (This indication is not be to used for the treatment of iron


Ac~lV.i! jngri!~ie11ts

Apium graveolens


Arctostaphylos uva-ursi

Equivalent: Arctostaphylos uva-ursi (Dry)



Avena saliva


maintaining general well-being. The herbal ingredients may help women perform in peak

Poison Schedule

Capsule, hard

Oral

1 mg

10mg

3.12mg

12.5 mg

2.Smg

25mg

25mg



)

Equivalent: Avena saliva (Fresh}

Biotin


Calcium citrate


Camellia sinensis

Equivalent: Camellia sinensis (Dry}

Carica papaya

Cantella asiatica

Equivalent: Gentelia asiatica (Dry)

Cholecalciferol

Choline bitartrate

Chromium picofinate

Citrus bioffavonoids extract

Copper gluconate

Crataegus monogyna

Equivalent: Crataegus monogyna (Dry}

Cyanocobalamin

Cynara scolymus

Equivalent: Cynara scolymus (Fresh}


Dunafielfa safina


Equivalent: Eleutherococcus senticosus (Dry}

Equisetum arvense

Equivalent: Equisetum arvense (Dry}

Ferrous fumarate

Foeniculum vulgare

Equivalent: Foeniculum vulgare (Dry}

Fofic acid

Ginkgo biloba


Glycyrrhiza glabra

Inositol

Lutein

Selenomethionine

Silybum marianum

Spearmint Oil


Ubidecarenone

Vaccinium myrtillus

Vitis vinifera


Zingiber officinale


250 mg

25 microgram

100 mg

50mg

37.5mg

1.67mg

10 mg

5mg

1.25 mg

5mg

.0025mg

1.7mg

7.5 mg

TGAeBS

250 microgram

50 microgram

2.5 mg

1.25mg

5mg

12.5mg

100 microgram

25mg

42.5 mg

Bmg

1.88 mg

7.5 mg

25mg

5mg

32.7 microgram

2.23 mg

25mg

25mg

32.5 microgram

357 microgram

750 microgram

25mg

500 microgram

4.17 mg

12.5 mg

1.5 mg



)

)

TGAeBS

Equivalent: Zingiber officinale (Dry) 7.5 mg



Page 3 of3 Produced at 13.03.2014 at 12:03:48 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent lo the dale shown. Visit www.tga.gov.au for contact information

)

Public Summary '*!!W:ftl~'Xs'!§tL~~J~;.~~trsrf( ./ 91326

ARTG entry for Medicine Listed

Opticq

Sponsor Swisse Wellness Ply Ltd


ARTG Start Date

Product category

Status

Approval area

Product Type

15/10/2002

Medicine

Revoked

Listed Medicines

Single Medicine Product


Eyes formula. Assists visual fatigue and eye-strain.,

Eyes formula. Support of healthy eye function.,

Effective date


Maintenance of healthy eyes.,

Eyes formula. Helps eyes to adapt to variations in light intensity.

CLINICALS OPTICQ by Swisse has been developed by a professor strain. It is recommended for people who experience problem clinical studies, which showed certain ingredients in OPTICQ results relatively quickly.For better results: OPTICQ may be with Swisse Women's & Men's Ultivite, which act as a "foun

Poison Schedule

TGAeBS

ts to relieve visual fatigue and eye OPTICQ is based on the assessment of irected, OPTICQ may deliver positive

recommend you use this product in conjunction t nutrients necessary for general wellbeing.

Closure

Not recorded

Conditions

Not recorded


'§~ii'/''! J.1)9r,!!ci.!erlt~ :1: . - . ~~;-

Tagetes erecta

Equivalent: Tagetes erecta (Dry)

Tocopherols concentrate - mixed {low-alpha type)

Zinc oxide

Tablet, film coated

Oral

Information Not Provided

250 mg

3.93mg

165.29 mg

60mg

330 mg

37Bmg

24.89mg



Page 1of1 Produced at 13.03.2014 at 02:01 :21 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

Public Summary

'~·~ffi~ijW!~~(~~'!\~,~ri}'Y:::, ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

100431 Childvite 1

Medicine Listed



29/03/2004

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Austral sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme ion kept.,



All reports of adverse reactions or similar experiences associated with the use or adminis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,



TGAeBS

4/10/2007 11 :00:00 PM

elected herbs to promote calmness in very active children.

be

t Formula in powder form has been formulated specifically for children of all ages, including those e 1 has been specifically formulated with selected vitamins, minerals, antioxidants and herbs to hese ingredients are known to be important for well-being and the herbs have been selected to tension in very active children. Childvite 1 may also be used to assist the child to prepare for sleep. f medical researchers in consultation with parents to provide a pleasant tasting effervescent liquid

1. Medicine Component

Dosage Form



Ac\ivl! W9i~&ienis

Ascorbic acid

Biotin

Calcium carbonate


Poison Schedule

Oral Liquid, powder for

Oral

5mg/g

3 microgram/g

5.25mg/g





Cyanocobalamin

Ferrous sulfate • dried

Folic acid

Humulus lupulus

Equivalent: Humulus lupulus (Dry}

Magnesium aspartate

Manganese sulfate monohydrate

Matricaria recutita

Equivalent: Matricaria recutita (Dry)

Nicotinamide


Riboflavin sodium phosphate



) ©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distri

written approval from the Commonwealth.Further details can be found at http:l/www.tga.gov.

)


TGAeBS

200 microgram/g

200 microgram/g

200 ng/g

350 microgram/g

1 microgram/g

57.14 microgram/g

200 microgram/g

2.4 mg/g

" 50 microgram/g

375 microgram/g

1.5 mg/g

1 mg/g

Produced at 13.03.2014 at 11 :59:50 EST


)

J

Public Summary

·.~~.f]fu~~!l?t;'~f~ i;~t.~~ . ARTG entry for

TGAeBS

93095 Prosqn

Medicine Listed

Swisse Wellness Ply Ltd Sponsor


ARTG Start Date

Product category

Status

Approval area

18/02/2003

Medicine

Revoked

Listed Medicines

The listing of this medicine is subject to statutory conditions of listing and additional conditions of listing imposed by the subsection 28(3) of the Therapeutic Goods Act 1989 by notice in writing.



For the symptomatic relief of medically diagnosed benign prostatic hypertrophy.,

Aids, assists or helps in the maintenance or improvement of general well-bei

May assist in the management of medically diagnosed benign prostatic hy

CLINICALS PROSQN by Swisse has been developed by a pro function. PROSQN is based on the assessment of clinical st medically diagnosed benign prostatic hypertrophy (or hyper interrupted weak stream, urinary frequency, urgency a PROSQN may deliver positive results relatively q you use this product in conjunction with CLINICA body with the important nutrients necessary for g

,, ··--· -_._ -;-,-,. -

. '··.;·.~iii~?'~;

Cholecalciferoi"'·""··

Cucurbita pepo

Equivalent: Cucurbita pepo (Dry)

Curcuma longa

Equivalent: Curcuma longa (Dry)

Folicacid

Ganoderma lucidum

Equivalent: Ganoderma lucidum (Dry)

Glycyrrhiza glabra

Equivalent: Glycyrrhiza glabra (Dry)


gredients, to assist in normal prostate ROSQN to provide relief from the symptoms of

men!} such as difficulties in micturition, a hesitant n natural herbal ingredients. Used as directed,

effective when used on it's own, however we recommend FORMULA 1, which act as a "foundation" to provide the

Closure

Not recorded

Poison Schedule

Conditions

Not recorded


Tablet, film coated

Oral

Information Not Provided

1.25 microgram

25mg

500 mg

4mg

100 mg

250 microgram

2.75 mg

55mg

13.75 mg

55 mg



lsatis tinctoria

Equivalent: lsatis tinctoria (Dry)


Equivalent: Lycopersicon esculentum (Fresh)

Panax ginseng


Selenomethionine

Serenoa repens


Serenoa repens


Urtica dioica

Equivalent: Urtica dioica (Dry)


11 mg

55mg

10mg

3.5 g

5.5 mg

55mg

TGAeBS

16.25 microgram

100mg

1 g

217.5 mg

870 mg

62.Smg

1.13 g

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or com mere

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-cop


)

)

Public Summary

~.YWfu~Jtfg~~~t9;~r1@;• ARTG entry for

Sponsor

TGAeBS

120384 Venaxl

Medicine Listed



ARTG Start Date

Product category

Status

Approval area

Product Type

6/07/2005

Medicine

Revoked

Listed Medicines

Single Medicine Product

Do not take while on warfarin therapy without medical advice.,

Effective date

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements shoul

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of seleniu be exceeded.

Protects capillaries.,

Aids, assists or helps in the maintenance or improvement of general well-bein

Liver tonic.,

Maintain health of capillaries.,

Formula to support the liver.,

May assist blood circulation.

~~r~Jlilili:<ttJit~~5 ~i1;~f~~~~

rm

·'·~oute of Administrati 'i?' "ual Identification

A~t\lf~in~r~~i~~t~ . · •

Crataegus monogyna

Equivalent: Crataegus monogyna (Dry)

Cyanocobalamin

Cynara scolymus

Equivalent: Cynara scolymus (Fresh)


Folic acid

Levocarnitine

Magnesium amino acid chelate

Nicotinic acid


ped by a professor and contains scientifically validated enance of healthy heart tissue and function as well as

n the maintenance of healthy cholesterol level, which is so in the detoxification process and fat metabolism which assists provides support for healthy liver function. VENAXL may

when used on it's own, however we recommend you use this "foundation" to provide the body with the important nutrients necessary for erties.

Poison Schedule

Tablet, film coated

Oral

50mg

20mg

150 mg

600 mg

25 microgram

16.67 mg

500 mg

82.6464mg

250 microgram

50mg

250 mg

25mg



)


Selenomethionine

Silybum marianum

Ubidecarenone

TGAeBS

10mg

16.25 microgram

21.43 mg

25mg




)

Public Summary .~W'1il!~~;tgR~~t~:F"-t~=:>... s2813 Cerexl

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



3/02/2003

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b} Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme kept.,



All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the•£14

Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Where the medicine is a convential release folic acid supp additional conditions are as follows: Where the medici this medicine must comply with the dissolution req Where the medicine contains multiple active ing requirements in the United States Phamacop The dissolution characteristics for this medicin

of 100 micrograms or more per dosage unit, the ient, the dissolution characteristics for folic acid in

4th Edition (USP24) monograph for Folic Acid Tablets. acid in this medicine must compley with the dissolution

ional Supplements, as amended by its First Supplement. ants of the relevant USP24 monograph over the shelf life of

the product when stored under the cond es po

Effective date 411012007 11 :00:00 PM

rculation to the peripheral areas of the body such as the legs, hands and feet.,

ance of blood flow in the hands, feet and legs.,

For the symptomatic relief of tinnitus. [Warning S required]

Support of Memory and Stamina CLINICALS CEREXL by Swisse has been developed by a professor and contains scientifically validated ingredients that help maintain memory function and stamina. CEREXL is based on the assessment of clinical studies, which showed certain ingredients in CEREXL can improve short-term memory and enhance mental alertness. CEREXL helps improve brain function such as learning or concentration as well as helping relieve the symptoms of absentmindedness. Used as directed, CEREXL may deliver positive results relatively quickly.For better results: CEREXL may be effective when used on it's own, however we recommend you use this product in conjunction with Swisse Women's or Men's Ultivite, which act as a foundation to provide the body with the important nutrients for general wellbeing. Reduces muscular pain and leg cramps and improves blood circulation. Relieves symptoms of cold hands and feet.

Page 1 of2 Produced at 13.03.2014 at 02:01 :49 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

-~~~~~~~zff~~~~~#'1,f€tm~Mtj1J'.· Pack Size

Dosage Form



A.ctive liJ$ri1diel!ts


Cyanocobalamin

Folicacid

Ginkgo biloba


Glutamine

Lecithin liquid - soy phosphatidylserine-enriched soy

Levocarnitine

Magnesium aspartate

R,S-alpha Lipoic acid


Tyrosine


©Commonwealth of Australia.This work is copyright.You are not written approval from the Commonwealth.Further details can be


Poison Schedule

Tablet, film coated

Oral

TGAeBS

60mg

ialise the material without obtaining prior

e-copyright.htm.



)

Public Summary

~\lfu:T~~J~~.~~"J;~Jn~i:Y,=: ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Swisse Ultiboost Prostate

Medicine Listed



7/09/2004

Medicine

Revoked

Listed Medicines


TGAeBS

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements

This product contains selenium which is toxic in high Closes. A daily dose of 150 micrograms for adults of sel be exceeded.,

If symptoms persist consult your healthcare practitioner (or words to that effect).

For the symptomatic relief of medically diagnosed benign prostatic hypertrophy.,

May assist in the management of medically diagnosed benign prostatic hypertr

Aids, assists or helps in the maintenance or improvement of general well-

Swisse Ultiboost PROSTATE is based on 25 years of research Swisse Ultiboost PROSTATE is based on the assessment of the symptoms of medically diagQosed Benign Prostatic Hy micturition, a hesitant interrupted weak stream, urinary fre herbal ingredients. Used as directed, Swisse


Panax ginseng

Sefenomethionine

Serenoa repens

Serenoa repens

Urtica dioica



Tablet, film coated

Oral

ts, to assist in normal prostate function. redients in the formula provided relief from restate enlargement), including difficulties in

wisse Ultiboost PROSTATE is based on natural ively quickly.

1.25 microgram

25mg

25mg

250 microgram

2.75 mg

13.75 mg

11 mg

10mg

5.5 mg

16.25 microgram

217.5mg

100mg

62.5mg

30mg



TGAeBS


written approval from the Commonwealth.Further details can be found at ,http://www.tga.gov.au/about/website-copyright.htm.


... )

.J

Public Summary ~~tjl'!h;~i:Yt¥t~!{t,~17~t~: > .• ·· 110295 SWISSE STUDENT HD

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



28/09/2004

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aust sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme kept.,



All reports of adverse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the spons of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date oft

Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Colouring agents used in listed medicine for ingestion, othe be only those included in the list of 'Colourings permi http://www.tga.gov.au/industry/cm-colourings-oral-u


Pack Size

Dosage Form



Active Ingredients


4/10/2007 11 :00:00 PM

is inadequate. OR Vitamin supplements should not replace a balanced diet.,

rds to that effect).,

Poison Schedule

Capsule, hard

Oral



.. , )

Avena saliva



Calcium phosphate

Cyanocobalamin

Ginkgo biloba


Magnesium phosphate

Nicotinamide

Panax ginseng


Potassium phosphate - dibasic


Riboflavine

Smilax ornata

Equivalent: Smilax ornata (Dry)

Thiamine nitrate


©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/


TGAeBS

50mg

500 mg

25mg

160mg

10 microgram

5mg

250 mg

130mg

10mg

35mg

350 mg

65mg



)

TGAeBS

Public Summary ,~i:lmfu~~~til:r,~~t~t~n~iX:,<' 109294 Swisse Ultiboost Sleep

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed



20/09/2004

Medicine

Revoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aus sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreemen kept.,

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and sha to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request.,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine~ in relation to the inclusion of the medicine in the Register.,

All reports of adverse reactions or similar experiences associated with the use or ad minis of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso of listed medicines must retain records of such reports for a period of not less than 18 months fro of the report or reports.,


Where a listed medicine is distributed overseas as well as in Aus outside Australia which has or may have relevance to the quality, Manager Therapeutic Goods Administration, immediately the a ·

lbe

Colouring agents used in listed medicine for ingestion, othe be only those included in the list of'Colourings permit! · http://www.tga.gov.au/industry/cm-colourings-oral-u

tion 25 of the Therapeutic Goods Act 1989, shall

Dosage Form



Active lngredl~rit$ •·

Page 1 of2

10/12/2009 10:39:18 AM

based on the assessment of clinical studies and contains scientifically validated ingredients shown to act baby and wake up refreshed. ation of herbs clinically proven to promote calmness and relaxation, and to assist in relieving nervous tension and

Ultiboost SLEEP contains ingredients shown to decrease sleep latency {the time taken to fall asleep). assist with and stress and minimise sleep challenges.

Poison Schedule

Tablet, film coated

Oral


)

)

Anemarrhena asphodeloides

Glycyrrhiza glabra

Humulus lupulus

Magnesium orotate

Poria cocos

Valeriana officinalis

10mg

12.5mg

26.67 mg

100 mg

10mg

325mg

TGAeBS

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or'commercialise the material without obtaining prior



)

)

Public Summary ~!!lfi!h'~ryJ~f8~T§;E~'!~!ji ... · ..

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

114871 lmunxl

Medicine Listed



30/11/2004

Medicine

., ~evoked

Listed Medicines

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of a (b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Aus sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreeme kept., ·

The sponsor shall retain records of the distribution of the listed medicine for a period offive years and sh to the Office of Complementary Medicines, Therapeutic Goods Administration, upon request,

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine i in relation to the inclusion of the medicine in the Register ..

All reports of adv!')rse reactions or similar experiences associated with the use or administ of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponso , of listed medicines must retain records of such reports for a period of not less than 18 months fr of the report or reports.,

The sponsor shall not supply the listed medicine after the expiry date of the.

Where a listed medicine is distributed overseas as· well as in Au outside Australia which has or may have relevance to the qualit Manager Therapeutic Goods Administration, immediately the a

TGAeBS

be

Colouring agents used ·in listed medicine for ingestion, other be only those included in the list of 'Colourings permit! · http:i/www.tga.gov.au/industry/cm-colourings-oral-


12/04/2005

r a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

Relief of symptoms of mild upper respiratory infections. [Warnings S and COLD required],

Helps fight mild upper respiratory complaints. [Warnings Sand COLD required],

For the symptomatic relief of recurrent upper respiratory tract infections. [Warnings S and COLD required].

May assist in the management of recurrent upper respiratory tract infections. [Warnings S· and COLD required],


Relief of the symptoms of allergies. [Warning S required],

Relief of the symptoms of colds. [Warnings S and COLD required],

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required],

May help reduce the severity of the symptoms of colds. ]Warnings S and COLD required].




)

) /

May reduce the severity of colds. [Warning COLD required],

May reduce the duration of colds. [Warning COLD require.d],

May reduce the severity and duration of colds. [Warning COLD required],

For relief of mucous congestion.[Warnings S and COLD required],

TGAeBS

For the symptomatic relief of upper respiratory tract infections. [Warnings S and COLD required]

CLINICAL$ IMUNXL by Swisse has been developed by a professor and contains ingredients traditionally used and supported by clinical studiesto assist in immune challenging conditions such as colds or flu. IMUNXL is based on the assessment of traditional use and clinical studies, which showed that certain ingredients in IMUNXL provide relief from the symptoms associated with colds and flu such as a blocked or runny nose, dry cough, and mucous congestion. Used as directed, IMUNXL may deliver positive results relatively quickly. Best used when first symptoms occur or when your body is most vulnerable such as prior to winter or contact with sick people.For better results: IMUNXL may be effective when used on it's own, however we recommend you use this product in conjunction with Swisse Women's or Men's Ultivite, which act as a "foundation" to provide"iRJl!i&2[[~ important nutrients necessary for general wellbeing.

Dosage f'orm



A"'.tiye lngrJidients.;

Calcium ascorbate


Cupric sulfate pentahydrate

Magnesium aspartate

Olea europaea

Equivalent: Olea europaea (Dry)


©Commonwealth of Australia.This work


Poison Schedule

Oral

250 mg

68.61 mg

ransmit, distribute or commercialise the material without obtaining prior

.tga.gov.au/about/website-copyright.htm.



)

)

TGAeBS

Public Summary · ~ufi:iif!;iry tc)FABTG i;qiry;; · · ' 76578

''-::·::' " ,,,.,,;:· •• ,< -~:, ;- • ' - . _- .. , · .. _ .. , .. WOMEN'S ULTIVITE MULTI-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS FORMULA 1 DIETARY SUPPLEMENT capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Pr:.;duct.category

Status

Approval area

Medicine Listed (Export Only)



19/10/2000

Medicine

Revoked

Export only Medicines

Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain evid substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of , Offic Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,

The conditions applying to these goods when they are exported from Australia are given below:,

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than conditi n No. 8 and condi

Conditions applicable to the relevant category and class of therapeutic goods as specified.; or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

Temperature

Store below 30 degrees Celsius

Poison Schedule

Closure

Not recorded

Conditions

Not recorded



A.~tiVE!h"igr@ielJ~ · .• ·. ··

Apium graveolens






Avenasativa


Capsule, hard

Oral

Amber coloured powder in a clear hard gelatin capsule. Size 0 Length 21.4 mm Width 7.64 mm

1 mg

10 mg

3.12 mg

12.5mg

2.5 mg

25mg

25mg



)

) /


Bioflavonoids

Biotin


Calcium citrate


Camellia sinensis


Carica papaya

Centella asiatica


Cholecalciferol

Equivalent: Cholecalciferol (Dry)

Choline bitartrate

Chromium picolinate

Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cynara scolymus



Dunaliella salina

Equivalent: Dunaliella salina (Fresh)



Equisetum arvense


Ferrous fumarate

Foeniculum vulgare


Folicacid

Ginkgo biloba


Glycyrrhiza glabra

Equivalent: Glycyrrhiza g

Inositol

Lycopersicon e

Equivalent: L


Riboflavine

Selenomethionine

Silybum marianum

Equivalent: Silybum marianum (Dry)

Spearmint Oil

Tagetes erecta




250 mg

20mg

25 microgram

100 mg

50mg

37.5 mg

.1.67 mg

10mg

5mg

1.25 mg

3.75mg

15mg

7.55mg

1.7mg

7.5 mg

TGAeBS

150 microgram

50 microgram

2.5 mg

1.25mg

5 mg

12.5mg

1 mg

20mg

25mg

42.5mg

Smg

1.88mg

7.5 mg

25mg

5g

32.7 microgram

2.23mg

25mg

25mg

32.5 microgram

357 microgram

25mg

750 microgram

500 microgram

10mg

25mg



)

)

Ubidecarenone

Vaccinium myrtillus

Equivalent: Vaccinium myrtillus (Fresh)

Vitis vinifera

Equivalent: Vitis vinifera (Dry)


Zingiber officinale


TGAeBS

500 microgram

125 microgram

12.5 mg

4.17mg

500 mg

12.5mg

1.5 mg

7.5 mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the mate

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.ht


)

TGAeBS

Public Summary

~yJ~tm~~r~~,~~rg2~~i1; · 79766 SWISSE WOMEN'S ULTIBOOST MINERAL & HERBAL PRE-EVENT FORMULA Tablet - film coated bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed


36-38 Gipps Street, COLLINGWOOD, VIC, 3066

Australia

7/08/2001

Medicine

Revoked

Listed Medicines

Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request o Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,

A copy of a signed and dated certificate of analysis, which is not more than six months old, for the first the Head, Listing Treaties & Export Section, Chemical & Non Prescription Drug Branch within six mont


Conditions applicable to all therapeutic goods as specified in the document "Standard Con Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than co

Conditions applicable to the relevant category and class of therapeutic goods as specified in the or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1 " effective 1 July

Conditions applicable to all therapeutic goods as specified in the document Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1

Conditions applicable to the relevant category and class of therap or Listed Therapeutic Goods Under Section 28 of the Therape

4/02/2003

relieve cold hands and feet. [Warning S required],

hands, feet and legs.,

lation.,

I areas of the body such as the legs, hands and feet.,

boost stamina and memory for peak perform ance, has been designed by a professor to be used as a companion with ula 1 when an extra boost is required. Sw isse Women's UltiBoost can also prepare you for periods in your life where you

will be your body and faculties such as working overtime, travelling or giving presentations. It's all about assisting you to perform in peak condition and enhancing mental alertness, so Swisse Women's Uli!Boost should be taken before and during physi cal and mental exertion. The difference is that unlike Swisse Women's Ultivite Formula 1 that is used daily throughout the year for the ma intenance of general wellbeing, you only need to use Swisse Women's UI tiBoost when you feel you need that ·extra boost'.

Type

Bottle

Page 1 of2

Material

Not recorded

Life Time

2 Years

This is not an ARTG Certificate document.

Temperature


Closure

Not recorded

Conditions

Not recorded



)

Pack Size

NIA

Dosage Form



Cimicifuga racemosa

Equivalent: Cimicifuga racemosa (Dry)

Cimicifuga racemosa

Ginkgo biloba

Ginkgo biloba


Glutamine

Magnesium aspartate

Panax ginseng


Panax ginseng

Schizandra chinensis

Schizandra chinensis

Equivalent: Schizandra chinensis (Dry)

©Commonwealth of Australia.This work is copyright.You are not

written approval from the Commonwealth.Further details can be'


TGAeBS

Poison Schedule


Tablet, film coated

Oral

Extra large oval yellow mustard film coated tablet Length 23.20 mm Width 10.50 mm

SO mg

200 mg

cialise the material without obtaining prior

site-copyright.him.



)

)

TGAeBS

Public Summary 76577 WOMEN'S ULTIVITE MULTI-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS FORMULA 1 DIETARY

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

SUPPLEMENT .




19/10/2000

Medicine

Revoked


Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remai substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than cond n No. 8 and condi

Conditions applicable to the relevant category and class of therapeutic goods as specified or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

The sponsor shall hold stability data to support the claimed shelf life of the list provide stability data to the Head, Office of Medicines Authorisation,TGA stability studies. When an overseas importer accepts responsibility for pro that they have a written agreement to this effect from the overseas importer. T

e conditions. The sponsor will er accepts responsibility for

onsor's responsibility to ensure agreement to the Head, Office of

Medicines Authorisation, TGA upon request.

Dosage Form



~C:tl~! 11lgred!!lltli ·•

Apium graveolens



Equivalent: Arctostaphylos uva-ursi {Dry)


13/11/2008

Temperature Closure

Not recorded Not recorded

Poison Schedule

Conditions

Not recorded



Tablet, film coated

Oral

Extra large oval shaped light pink film coated tablet Length 23.2 mm Width 10.5 mm

2mg

20mg

6.25 mg

25mg


The onus is on the reader to verify the current accuracy of the information on the document subsequent to the dale shown. Visit www.tga.gov.au for contact information

,,

)

)

TGAeBS

Astragalus membranaceus 5mg

Equivalent: Astragalus membranaceus (Dry) 50mg

Avena sativa 50mg

Equivalent: Avena saliva (Fresh) 500 mg

Biotin 50 microgram

Calcium ascorbate dihydrate 200 mg

Calcium citrate 200 mg

Calcium pantothenate 75mg

Camellia sinensis 3.34mg

Equivalent: Camellia sinensis (Dry) 20mg

Carica papaya 10mg

Centella asiatica 2.5 mg


Choline bitartrate

Chromium picolinate


Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cynara scolymus





Equisetum arvense

Equivalent: Equisetum arvense (Dry) 30mg

Ferrous fumarate 16.01 mg

Foeniculum vulgare 3.41 mg

Equivalent: Foeniculum vulgare (Dry) 15 mg

Folic acid 300 microgram

Ginkgo biloba 100 microgram

Equivalent: Ginkgo biloba (Dry) 5mg

Glycyrrhiza glabra 2.5mg

10mg

Inositol 25mg

50mg

81.46mg

16mg

3.75mg

15mg

50mg

10mg

66 microgram

4.45mg

50mg

50mg

65 microgram

Spearmint Oil 1.5mg

Thiamine hydrochloride 50mg

Ubidecarenone 1 mg

Zinc amino acid chelate 25mg

Zingiber officinale 3mg

Equivalent: Zingiber officinale (Dry) 15 mg


~

& i---' li--l •

0 (/l ~ s s ~

~

_)

TGAeBS




)

TGAeBS

Public Summary 76576 WOMEN'S ULTIVITE MULTI-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS NO IRON OR IODINE

DIETARY SUPPLEMENT tablet jar

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area

Medicine Listed (Export Only}



19/10/2000

Medicine

Revoked


Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be resp on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain evid substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of , Office Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condi · No. 8 and condi

Conditions applicable to the relevant category and class of therapeutic goods as specifie or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

load (hemochromatosis}, or should not take iodine.

4~tivli' 1o~r~<:1•~~bi'

Apium graveolens






Avena sativa


Page 1 of3 This is not an ARTG Certificate c!ocument.

Temperature


Poison Schedule

Closure

Not recorded

Conditions

Not recorded



Tablet, film coated

Oral

Extra large oval white film coated tablet. Length 23.2 mm Width 10.5 mm

2mg

20mg

6.25mg

25mg

5mg

50mg

50mg

500 mg


The onus is on the reader to verify the current accuracy of the information on the document subsequenfto the date shown. Visit www.tga.gov.au for contact information

)

Bioflavonoids

Biotin


Calcium citrate


Camellia sinensis


Carica papaya

dmtella asiatica


Cholecalciferol

Choline bitartrate

Chromium picolinate

Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cynara scolymus



Dunaliella salina




Equisetum arvense


Foeniculum vulgare


Folicacid

Ginkgo biloba


Glycyrrhiza glabra

Equivalent: Glycyrrhiza glabra (Dry

Inositol

Spearmint Oil

Tagetes erecta




Ubidecarenone

Vaccinium myrtillus


Vitis vin if era


40mg

50 microgram

50mg

200 mg

75mg

3.34mg

20 mg

5mg

2.5 mg

10 mg

25mg

15mg

TGAeBS

300 microgram

100 microgram

5mg

2.5 mg

10mg

25mg

2mg

40mg

92mg

16mg

3.75mg

15mg

50mg

5mg

4.45mg

50mg

50mg

65 microgram

14.29mg

1 g

1.7mg

1 mg

20mg

50mg

3.36mg

1 mg

250 microgram

25mg

8.34 mg



)



Zingiber officinale

Equivalent: Zingiber officinale (Dry}

1 g

25mg

3mg

15 mg

TGAeBS


written approval from the Commonwealth.Further details can be found at http://Www.tga.gov.au/about/website-copyright.htm.


)

)

TGAeBS

Public Summary 76575 WOMEN'S ULTIVITE MUL Tl-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS NO IRON OR IODINE

DIETARY SUPPLEMENT capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area


Swisse Wellness Ply ltd


19/10/2000

Medicine

Revoked


.(

Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r • on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain iden substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of , Offi Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director ..


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than cond No. 8 and condi

Conditions applicable to the relevant category and class of therapeutic gooi;ls as specifre or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

1. WOMEN'S ULTIVITE MULT-VITAMIN MINERAL & ANT DIETARY SUPPL

Product Type

load (hemochromatosis) or should not take Iodine.

.Actiife Ingrediilrib! · .·

Apium graveolens






Avena saliva


Temperature


Poison Schedule

Closure

Not recorded

Conditions

Not recorded



Capsule, hard

Oral

Amber coloured powder in a clear hard gelatin capsule Size O Length 21.4 mm Width 7.64 mm

1 mg

10 mg

3.12 mg

12.5 mg

2.5 mg

25mg

25mg


Th·e onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

)

)


Bioflavonoids

Biotin


Calcium carbonate


Camellia sinensis


Carica papaya

Cantella asiatica


Cholecalciferol

Choline bitartrate

Chromium picolinate

Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cynara scolymus



Dunaliella salina




Equisetum arvense


Foenicu.lum vulgare


Folic acid

Ginkgo biloba


Glycyrrhiza glabra

Inositol


Spearmint Oil

Tagetes erecta




Ubidecarenone

Vaccinium myrtillus


250 mg

20mg

25 microgram

25mg

55.55mg

37.5mg

1.67mg

10 mg

2.5mg

1.25mg

1.7 mg

7.5 mg

TGAeBS

150 microgram

50 microgram

2.5 mg

1.25 mg

5mg

12.5mg

1 mg

20mg

46mg

8mg

1.88mg

7.5 mg

25mg

2.5mg

2.23 mg

25mg

25mg

32.5 microgram

7.14mg

500 mg

750 microgram

500 microgram

10mg

25mg

1.68 mg

500 microgram

125 microgram

12.5 mg


)

Vitis vinifera



Zingiber offlcinale


4.17 mg

500 mg

12.5 mg

1.5mg

7.5 mg

TGAeBS



Page 3 of3 Produced at 13.03.2014 at 01:53:22 EST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of. the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information

_)

)

TGAeBS

Public Summary 76573 MEN'S ULTIVITE MULTI-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS FORMULA 1 DIETARY

SUPPLEMENT

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area




19/10/2000

Medicine

Revoked


Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain I evid substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of , Offi Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condi · No. 8 and condi

Conditions applicable to the relevant category and class of therapeutic goods as specified or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

The sponsor shall hold stability data to support the claimed shelf life of the list provide stability data to the Head, Office of Medicines Authorisation,TGA up stability studies. When an overseas importer accepts responsibility for provi · that they have a written agreement to this effect from the overseas impo.rter. Th Medicines Authorisation, TGA upon request.

Poison Schedule

13/11/2008

onditions. The sponsor will er accepts responsibility for

sponsor's responsibility to ensure agreement to the Head, Office of



Actiye l•t~fr"'d(enti.

Apium graveolens



Equivalent: Astragalus membranaceus (Dry)·

Avena sativa


Barosma betulina



Tablet, film coated

Oral

Extra large oval green film coated tablet Length 23.2 mm Width 10.5 mm

2mg

20mg

5mg

50mg

50mg

500 mg

2.5 mg

10 mg



J

~)

TGAeBS

Berberis vulgaris 2.5mg

Equivalent: Berberis vulgaris (Dry) 15 mg

Biotin 50 microgram

Calcium ascorbate dihydrate 200 mg

Calcium ci~rate 100 mg

Calcium pantothenate 70mg

Camellia sinensis 3.34mg

Equivalent: Camellia sinensis (Dry) 20mg

Carica papaya 10mg

Centella asiatica 12.5mg

Equivalent: Centella asiatica (Dry) 50mg

Choline bitartrate 25mg

Chromium picolinate


Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cynara scolymus


Equisetum arvense


Ferrous fumarate

Foeniculum vulgare


Folic acid

Ginkgo biloba


Inositol 25mg

Lysine hydrochloride 50mg

Magnesium oxide - heavy 100 mg

Manganese amino acid chelate· 12mg

Nicotinamide 30mg

Panax ginseng 16.67 mg

50mg

Petroselinum crispum 10mg

66 microgram

8.92 mg

30mg

30mg

65 microgram

20mg

200 mg

12.5 mg

50mg

1.5 mg

30mg

24mg

Equivalent: Turnera diffusa (Dry) 120 mg

Tyrosine 1 mg

Ubidecarenone 1 mg

Zinc amino acid chelate 30mg

Zingiber officinale 1 mg

Equivalent: Zingiber officinale (Dry) 5mg


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0

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)

TGAeBS




)

TGAeBS

Public Summary 76574 MEN'S ULTIVITE MULTI-VITAMIN MINERAL & ANTI- OXIDANT WITH HERBS FORMULA 1 DIETARY

SUPPLEMENT capsule bottle

ARTG entry for

Sponsor

Postal Address

ARTG Start Date

Product category

Status

Approval area




19/10/2000

Medicine

Revoked


Except where the sponsor has been contracted by an overseas party to manufacture the goods and that party will be r on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain substantiate and support the accuracy of the indications in relation to the listed goods and, upon the request of Authorisation, Therapeutic Goods Administration, shall produce such evidence to the Director.,


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than cond No. 8 and con

Conditions applicable to the relevant category and class of therapeutic goods as specifie or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1

Temperature


Poison Schedule

Closure

Not recorded

Conditions

Not recorded



Apium graveolens




Avena saliva


Barosma betulina


Capsule, hard

Oral

Amber coloured powder in a clear hard gelatin capsule Size 0 Length 21.4 mm Width 7.64 mm

1 mg

10mg

2.5mg

.25mg

25mg

250 mg

1.25mg



)


Barberis vulgaris ·


Bioflavonoids

Biotin


Calcium citrate


Camellia sinensis


Carica papaya

Centella asiatica


Cholecalciferol

Choline bitartrate

Chromium picolinate

Copper gluconate

Crataegus monogyna


Cyanocobalamin

Cyriara scolymus



Dunaliella salina

Equivalent: Dunaliella salina (Fresh}

Equisetum arvense


Ferrous fumarate

Foeniculum vulgare


Folic acid

Ginkgo biloba


Inositol

Serenoa repens


Silybum marianum


Smilax officinalis

Equivalent: Smilax officinalis (Dry)

Spearmint Oil

Tagetes erecta



5mg

1.25 mg

7.5mg

20mg

25 microgram

100 mg

50mg

35mg

1.67 mg

10mg

4.56mg

1.7 mg

7.5 mg

TGAeBS

150 microgram

1 mg

50mg

12.5 mg

1 mg

20 mg

25mg

50mg

6mg

15mg

8.33 mg

25mg

5mg

33 microgram

4.46 mg

15mg

15mg

32.5 microgram

10mg

100 mg

357 microgram

25mg

6.25 mg

25mg

750 microgram

500 microgram

10mg



)

)


Turnera diffusa


Tyrosine

Ubidecarenone

Vaccinium myrtillus


Vitis vinifera

Equivalent: Vilis vinifera (Dry)


Zingiber offlcinale


15mg

12mg

60mg

TGAeBS

500 microgram

500 microgram

125 microgram

12.5mg

4.17 mg

500 mg

15mg

©Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or com mer ·

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/web


FOI 127-1314 document 24 part 2

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Transcript of FOI 127-1314 document 24 part 2